System for manufacturing a polymer endoprosthesis by injection molding and blow molding

ABSTRACT

A polymer endoprosthesis is fabricated by a combination of injection molding and blow molding which form a tubular substrate of polymer material, followed by laser cutting, crimping and sterilization. After the injection and blow molding processes, a subtractive process is performed on the tubular substrate to transform it into a stent having a network of stent struts. The tubular substrate can be made in an injection mold and blow mold which are attached to each other. The transition from injection molding and blow molding can be performed while the injection molded substrate remains at a temperature at or above Tg of the polymer material.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of application Ser. No. 13/114,941,filed on May 24, 2011, which application is incorporated herein byreference.

FIELD OF THE INVENTION

This invention relates generally to fabrication of implantableendoprostheses, more particularly, to fabrication of polymer stents frominjection molded and blow molded tubes.

BACKGROUND OF THE INVENTION

An endoprosthesis is an artificial device that is placed inside a humanor animal body. An anatomical lumen is a cavity of a tubular organ suchas a blood vessel. Stents are generally cylindrically shaped devices,which function to hold open and sometimes expand a segment of a bloodvessel or other anatomical lumen such as urinary tracts and bile ducts.Stents are often used in the treatment of atherosclerotic stenosis inblood vessels. In such treatments, stents reinforce blood vessels andprevent restenosis following angioplasty in the vascular system.

Stents are relatively small, as they are often required to be passedthrough tight confines of anatomical lumens. A stent must often havegreat longitudinal flexibility to allow it to pass through tortuouscurves of anatomical lumens. Stents typically comprise a fine network ofstruts which form a tubular scaffold. The tubular scaffold must often becapable of being crimped onto a delivery device, such as a balloon, toreduce its size to allow passage through anatomical lumens, and thenforcibly expanded by the balloon to an enlarged, deployed state at thedesired location within the body. For some stents, the tubular scaffoldmust be capable of self-expanding from its crimped state at the desiredlocation within the body. After implantation and deployment, the tubularscaffold must have sufficient strength to support surrounding anatomicalstructures. Thus it will be appreciated that stents present uniquedesign challenges.

Stents have in the past been made of metals, such as nickel-titaniumalloys having shape memory and superelastic properties. The advent ofpolymer stents have presented further design challenges. The design of apolymer stent must take into account that, as compared to metal stentsof the same dimensions, polymer stents typically have less radialstrength and rigidity and less fracture toughness. Thus, there is acontinuing need for a method and system for manufacturing polymer stentsthat (a) increase uniformity from stent to stent, (b) allow for tightcontrol of design parameters, such as the thickness and dimension ofindividual stent struts, and/or (c) increase manufacturing efficiency.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention is directed to amethod and system for forming a polymer endoprosthesis.

In aspects of the present invention, a method comprises injecting apolymer material into a cavity of a first mold in order to form a stocktube, placing the stock tube in a cavity of a second mold, wherein thestock tube enters the second mold as it exits the first mold, andexpanding the stock tube to form a precursor tube within the secondmold.

In aspects of the present invention, a method comprises forming a stocktube of polymer material in an injection mold, transferring the stocktube from the injection mold to a blow mold, the transferring stepperformed while the stock tube is at a temperature at or above Tg of thepolymer material, and expanding the stock tube in the blow mold in orderto form a precursor tube.

In aspects of the present invention, a system comprises an injectionmold having an injection mold cavity, a blow mold having a blow moldcavity, and a door movable from an first position to a second position,the injection mold cavity and the blow mold cavity being separated fromeach other by the door when at the first position, the injection moldcavity and the blow mold cavity being exposed to each other with whenthe door is at the second position.

The features and advantages of the invention will be more readilyunderstood from the following detailed description which should be readin conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is flow diagram showing a method according to some embodiments ofthe present invention.

FIG. 2A is a cross-section view of a system according to someembodiments of the present invention, showing the system prior toinjection of a polymer resin.

FIG. 2B is a cross-section view of the system of FIG. 2A, showing thesystem after polymer resin is injected into an injection mold cavity.

FIG. 2C is a cross-section view of the system of FIG. 2A, showing thesystem after the polymer resin, referred to as a stock tube, is ejectedin a non-molten state directly into a blow mold cavity.

FIG. 2D is a cross-section view of the system of FIG. 2A, showing thesystem after the stock tube is radially expanded against an interiorsurface of the blow mold cavity.

FIG. 2E is a cross-section view of the expanded polymer resin, referredto as a precursor tube, after having been removed from the blow mold.

FIG. 2F is a cross-section view of the precursor tube carried on amandrel, showing a cutter removing material from the precursor tube inorder form stent struts.

FIGS. 3A-3F are perspective views of a system according to someembodiments of the present invention, showing a stock tube formed frompolymer resin injected into an injection mold, and showing a precursortube formed from the stock tube having been expanded in a blow mold, andshowing a stent being formed by removal of material from the precursortube.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

All publications and patents mentioned in the present specification areincorporated herein by reference to the same extent as if eachindividual publication or patent was specifically and individuallyindicated to be incorporated by reference. To the extent there are anyinconsistent usages of words and/or phrases between an incorporatedpublication or patent and the present specification, these words and/orphrases will have a meaning that is consistent with the manner in whichthey are used in the present specification.

As used herein, any term of approximation such as, without limitation,near, about, approximately, substantially, essentially and the like meanthat the word or phrase modified by the term of approximation need notbe exactly that which is written but may vary from that writtendescription to some extent. The extent to which the description may varywill depend on how great a change can be instituted and have one ofordinary skill in the art recognize the modified version as still havingthe properties, characteristics and capabilities of the modified word orphrase. For example without limitation, a material that is described as“substantially at ambient room temperature” refers to a material that isperfectly stabilized at room temperature and a material that one skilledin the art would readily recognize as being at room temperature eventhough some areas of the material are not perfectly at room temperature.In general, but with the preceding discussion in mind, a numerical valueherein that is modified by a word of approximation may vary from thestated value by ±15%, unless expressly stated otherwise.

Referring now in more detail to the exemplary drawings for purposes ofillustrating embodiments of the invention, wherein like referencenumerals designate corresponding or like elements among the severalviews, there is shown in FIG. 1 a flow diagram of a method formanufacturing a polymer endoprosthesis which involves a combination ofinjection molding, blow molding, and formation of stent struts.Injection molding is performed first and is followed by deformation ofthe injection molded item, then forming the network or pattern of stentstruts from the deformed injection molded item.

Methods of injection molding a polymer stent have been described in, forexample, U.S. Pub. No. 2008/0001330 of application Ser. No. 11/477,333filed Jun. 28, 2006. In prior methods, the network of stent struts wasformed during the injection molding process. A potential difficulty inhaving stent struts formed directly through injection molding is thatthe mold cavity will have grooves that correspond to the intricateshapes and pattern of the desired stent struts. The polymer resin wouldhave to flow through the network of grooves that can be 0.1 mm wide and0.1 mm deep, or even smaller. Depending on the actual width and depth ofthe grooves, the viscosity of the molten resin, and manufacturingthroughput requirements, it may be impractical to have stent strutsformed directly from injection molding.

In some embodiments of present invention, none of the stent struts inthe finished stent are formed through injection molding. In alternativeembodiments, some stent struts are formed through injection molding (anadditive process) and other stent struts on the same stent are formed ata later time by removal of material (a subtractive process) as describedbelow.

Prior to formation of the stent struts by a subtractive process, changesare made to the mechanical characteristics of the injection molded itemfrom which the stent struts will later be formed. The structure fromwhich stent struts are formed, such as the injection molded item of thepresent invention, is referred to herein as the “substrate.” In general,a substrate can be a flat sheet or a cylindrical tube. After injectionmolding, the mechanical characteristics of the substrate can be changedby inducing deformation, such as by stretching, in one or moredirections. Such deformation causes polymer molecule chains to becomeoriented in a particular direction and/or causes polymer crystallizationand growth in a particular direction. These morphological changesinvolving microstructure orientation give the substrate the desiredmechanical characteristics which will allow a network of stent struts,subsequently formed from the substrate, to have the necessary balancebetween flexibility, strength, and fracture toughness.

Methods of deforming the injection molded substrate can involve blowmolding. For a description of blow molding, see, for example, U.S. Pub.No. 2009/0001633 of application Ser. No. 11/771,967 filed Jun. 29, 2007and U.S. Pub. No. 2011/0066222 of application Ser. No. 12/558,105 filedJun. 28, 2006.

Referring again to FIG. 1, in block 10 polymer material is heated untilit is molten, then injected under pressure into the cavity of a firstmold. The cavity of the first mold is annular in shape. The first moldis configured to form a tube of the polymer, which is a substrate fromwhich stent struts will be formed at a later time. At this stage (priorto making morphological changes to the substrate), the substrate isreferred to as a “stock tube.” The shape and dimensions of the stocktube corresponds to those of the annular mold cavity. The stock tube iscylindrical and has a circumferential wall having a predetermined wallthickness. The wall thickness is carefully selected to provide optimalresults in the finished stent. The wall thickness can be, withoutlimitation, about 1 mm. The thickness can be selected based in part onthe polymer material being used and the amount of expansion thesubstrate will be subjected to at a later time. Optionally, thecircumferential wall has no radial perforations though there can beaxial openings at the opposite ends of the circumferential wall.

In some embodiments, the method proceeds to block 15 in which the stocktube is released from the first mold while still at a temperaturegreater than the glass temperature (Tg) of the polymer material butlower than the melt temperature (Tm) of the polymer material. Tg is thetemperature at which the amorphous domains of a polymer change from abrittle vitreous state to a solid deformable or ductile state atatmospheric pressure. Tg corresponds to the temperature where the onsetof segmental motion in the chains of the polymer occurs. Between Tg andTm rotational barriers exist, however, the barriers are not great enoughto substantially prevent segmental mobility.

The polymer material is at a temperature substantially below Tm whenreleased from the first mold. It is to be understood that the stock tubeis in a substantially non-molten state when it comes out of the firstmold, even though it is at a temperature at or above Tg. Having thestock tube substantially non-molten helps to ensure that thecircumferential wall thickness is not inadvertently altered in the timeperiod between release from the first mold (block 15) and expansion inthe second mold (block 25 discussed below). This non-molten state of thestock tube upon release from the first mold is distinct from extrusionprocesses in which an extruded polymer is substantially molten when itexits an extruder die.

The stock tube is released from the first mold after the flow of polymermaterial in the mold cavity has substantially stopped. This condition isdistinct from extrusion processes in which the polymer materialcontinues to flow through the extruder cavity while exiting the extruderdie.

Next in block 20, before the stock tube has cooled to a temperaturesubstantially below Tg, the stock tube is placed in the cavity of asecond mold, which can be a glass-lined blow mold. The cavity has aninner diameter that is greater than the outer diameter of the stocktube.

In some embodiments of the present invention, at least some portions ofthe first mold are contained within the cavity of the second mold. Uponcompletion of polymer material injection, those portions of the firstmold can open and thereby eject or release the stock tube directly fromthe first mold cavity and into the cavity of the second mold. Thisdirect transfer of the stock tube from the first mold to the secondmold, without exposure to external atmospheric conditions and handling,eliminates or minimizes cooling of the stock tube and eliminates orminimizes the chance of inadvertent alteration of the circumferentialwall thickness prior to expansion in the second mold (block 25 discussedbelow).

Next in block 25, the internal fluid pressure of the stock tube isincreased, such as by pumping a gas into the stock tube. The internalfluid pressure is increased to a level which causes the circumferentialwall of the stock tube (i.e., substrate) to stretch and expand radiallyoutward against the surfaces of the second mold cavity, thereby changingthe mechanical characteristics of the substrate. The surfaces of thesecond mold cavity limit the outward radial expansion of thecircumferential wall.

Upon completion of block 25, after changes to the mechanicalcharacteristics of the substrate have been made, the substrate isreferred to as a “precursor tube.”

In some embodiments, substantially the entire longitudinal length of thestock tube is radially expanded simultaneously. In alternativeembodiments, expansion of the stock tube occurs in a progressive manner,as described in Pub. No. 2011/0066222, in which a limited longitudinalsegment of the stock tube is radially expanded at any one time, and thedeformation propagates longitudinally over a period of time from one endof the stock tube to the other end.

By keeping the substrate at a temperature above Tg during transfer fromthe first mold to the second mold, manufacturing time is decreased byeliminating or reducing the need to reheat the substrate to atemperature necessary for expansion. In some embodiments, the substratehas not cooled to a temperature below a predetermined processtemperature (Tp) prior to expansion of the substrate, thereby allowingexpansion to be performed substantially without applying heat to thesubstrate. The process temperature is carefully predetermined to provideoptimal results in the finished stent. Typically, Tp is between Tg andTm. Tp can depend in part on the composition of the polymer material andthe desired amount of radial expansion. For example, Tp can be fromabout 160 degrees F. to about 220 degrees F. when the polymer materialbeing used is poly(L-lactide). Without limitation, the composition ofthe polymer material, levels for Tp, internal fluid pressure, radialexpansion ratio, axial extension ratio, and other blow moldingparameters can be as described in U.S. Pub. No. 2011/0066222 ofapplication Ser. No. 12/558,105 filed Jun. 28, 2006.

In some embodiments, the substrate is heated during or before expansionof the circumferential wall, even though the substrate has not cooled toa temperature below Tg subsequent to removal from the first mold. Theapplication of heat in block 20 and/or block 25 can help ensureuniformity in temperature and uniformity in the resultant mechanicalcharacteristics. The application of heat may be needed to bring thestock tube to a temperature at or about Tp.

Next in block 30, the precursor tube is removed from the second mold. Insome embodiments, the precursor tube which is removed from the secondmold is used as an endoprosthesis.

Continuing from block 30 to block 40, material is removed from theprecursor tube, in what is referred to as a subtractive process, inorder to form a stent having a network of stent struts. Material isremoved from the precursor tube so that what remains of the precursortube is the network of stent struts. Material can be removed with acutter, which can be sharp blade and/or a laser cutting tool. For adescription of laser removal from a polymer substrate, see, for example,U.S. Pat. No. 7,622,070 issued Nov. 24, 2009.

Next in block 50, the stent is sterilized, making it ready forimplantation within a patient. Sterilization can be performed in anynumber of ways, such as by ethylene oxide gas or electron beam (E-beam)radiation.

Alternatively, as shown in block 45, the stent can be mounted onto acatheter prior to sterilization. Mounting can involve crimping the stentonto an inflatable balloon of the catheter.

Alternatively, as shown in block 40, a coating can be applied to thestent prior to sterilization or prior to mounting the stent onto acatheter. The composition of the coating and any drugs carried thereincan be as described in any of the publications which are cited andincorporated herein by reference.

In alternative embodiments of the present invention, the method canproceed from block 10 to block 17 in which the stock tube is releasedfrom the first mold at any temperature. For example, the stock tube canbe removed from the first mold after the polymer material in theinjection mold cavity has cooled to a temperature T, where T<Tg or whereTg<T<Tm.

Continuing from block 17 to block 22, the stock tube is placed in thecavity of a second mold. The cavity has an inner diameter that isgreater than the outer diameter of the stock tube. This step can beperformed after the stock tube is at a temperature about the same asambient room temperature, such as in situations where the stock tube hasbeen stored for a long period of time prior to placement in the secondmold. Alternatively, this step (placing the stock tube in the secondmold) can be performed while the stock tube is still at a temperaturesubstantially above room ambient temperature due to heat from injectionmolding. Alternatively, this step (placing the stock tube in the secondmold) can be performed while the stock tube is at a temperaturesubstantially below ambient room temperature, such as in situationswhere the stock tube has been actively cooled or quenched within thefirst mold or upon removal from the first mold.

Next in block 27, the internal fluid pressure of the stock tube (i.e.,substrate) is increased, such as by pumping a gas into the stock tube,in order to cause expansion and produce the precursor tube. Expansion isthe result of a pressure differential in which fluid pressure outside ofthe stock tube is lower than pressure inside the stock tube. While thesubstrate is in the second mold, the substrate is heated to a processtemperature (Tp) above Tg and below Tm. Parameters such as internalfluid pressure, Tp, and others can be as previously described inconnection with block 25.

The method proceeds from block 27 to blocks 30-50 previously describedwith optional application of a drug coating and optional mounting onto acatheter.

As indicated above, the method can include a series of steps with blocks15, 20 and 25, or alternatively, a series of steps with blocks 17, 22and 27. The method with blocks 15, 20 and 25 is optionally performed asdescribed below in connection with FIGS. 2A-2F. The method with blocks17, 22 and 27 is optionally performed as described below in connectionwith FIGS. 3A-3F. It is to be understood that the method described abovein connection with blocks 10-50 can be performed using systems otherthan those shown in FIGS. 2A-3F.

FIGS. 2A-2F show a system for manufacturing a polymer endoprosthesis,with each figure illustrating a sequential step.

An injection molding process is shown in FIGS. 2A and 2B. Injection mold100 includes cavity 102 into which molten polymer resin is injectedthrough gate 104. The cavity is configured to produce a stock tube. Thecavity is cylindrical in shape and is bounded by inner circumferentialsurface 106 and outer circumferential surface 108 of mold 100. Thedistance between circumferential surfaces 106 and 108 defines thethickness of the circumferential wall of the resultant stock tube. Outercircumferential surface 108 defines a maximum diameter 109 of injectionmold cavity 102. The size and shape of the exterior surface of theresultant stock tube will correspond to the outer circumferentialsurface 108. Inner circumferential surface 106 is provided by mold core110 in the shape of a cylindrical rod. The size and shape of theinterior lumen of the resultant stock tube will be that of mold core110.

FIG. 2B shows polymer resin 112 having been injected through injectiongate 104 and into injection mold cavity 102. It is to be understood thatthere can be one or more injection gates and that the injection gatescan be arrange and oriented in any suitable manner, such as to preventvoids and other structural defects in the resultant stock tube. When theflow of polymer resin 112 into injection mold cavity 102 has stopped andafter polymer resin 112 has cooled to a temperature below Tm, door 114slides from a closed position shown in FIG. 2B to an open position shownin FIG. 2C. Door 114 can be pneumatically or electrically controlled.

As shown in FIG. 2C, movement of door 114 allows the non-molten polymerresin, referred to now as stock tube 116, to be released from injectionmold 100 and placed into blow mold 120. Injection mold 100 and blow mold120 are connected to each other such that movement of door 114 exposesstock tube 116 to cavity 122 of blow mold 120. With door 114 at its openposition, injection mold cavity 102 and blow mold cavity 122 form acommon, enlarged cavity that is substantially sealed from the external,ambient environment by the interconnected housings 101 and 121 ofinjection mold 100 and blow mold 112. With door 114 open, injection moldcavity 102 and blow mold cavity 122 are exposed to each other. Afterdoor 114 has opened, ejector 119 pushes stock tube 116 out of injectionmold cavity 102 and directly into blow mold cavity 122. Ejector 119 canbe pneumatically or electrically controlled. Stock tube 116 istransferred from injection mold cavity 102 into blow mold cavity 122while shielded from the external, ambient environment.

Blow mold cavity 122 is bounded by circumferential surface 124 whichdefines a maximum diameter 125 of the blow mold cavity 122. Diameter 125is greater than maximum diameter 109 of injection mold cavity 102, whichthus allows space for stock tube 116 to expand radially outward.

There are axial openings at opposite end segments 117 and 118 of stocktube 116. First end segment 117 remains partially contained withininjection mold 100 so that the axial opening at first end segment 117 issealed against fluid flow. Second end segment 118 is engaged againstconical member 128 of blow mold 120. Conical member 128 is wedged intosecond end 118 to prevent fluid flow through the interface betweensecond end 118 and conical member 128. Gas passageway 130 extendsthrough the center of conical member 118 and is in communication withthe interior of stock tube 116.

FIG. 2D shows the result after gas is pumped through gas passageway 130and into the interior of stock tube 116. The gas has increased the fluidpressure within the interior of stock tube 116 to a level which causedthe circumferential wall of stock tube 116 to expand radially outwardand press against circumferential surface 124 of blow mold cavity 122.Blow mold 120 can include vent 131 in its housing 121 to allow gasbetween the circumferential wall of stock tube 116 and circumferentialsurface 124 of blow mold cavity 122 to escape during expansion of thecircumferential wall. After expansion is completed, blow mold 120 can beopened to allow for removal of the expanded stock tube, now referred toas precursor tube 134. For example, conical member 128 can be retractedout of blow mold 120 to provide an opening through which precursor tube134 can pushed by ejector 119 of injection mold 100.

FIG. 2E shows precursor tube 134 after having been removed from blowmold 120.

As shown in FIG. 2F, precursor tube 134 can be carried on cylindricalmandrel 136 and placed adjacent cutter 138 for removing portions ofprecursor tube 134 to form a network of stent struts. Perforation 139has been made by cutter 138 through precursor tube 134. With removal ofmaterial, precursor tube 134 is transformed to a stent having a networkof stent struts. Mandrel 136 is inserted within precursor tube 134 andcan be connected to rotation and slide motor and gear assembly 40 undercomputer numerical control (CNC). Relative movement between mandrel 136and cutter 138 can be programmed into a CNC software applicationoperating within electronic controller 142 to provide the desiredpattern of stent struts.

FIGS. 3A-3F show a system for manufacturing a polymer endoprosthesis,with each figure illustrating a sequential step.

An injection molding process is shown in FIGS. 3A and 3B. Injection mold200 includes cavity 202 into which molten polymer resin is injected.Mold cavity 202 is configured to produce stock tube 116 having acircumferential wall with a predetermined wall thickness.

FIG. 3B shows two halves of injection mold 200 separated to expose moldcavity 202 and allow stock tube 116 to be ejected out from mold cavity202. Prior to ejection, a mold core can retracted out from the interiorof stock tube 116. There are axial openings at opposite end segments117, 118 of stock tube 116. In some embodiments, stock tube 116 has onlyone axial opening in which end segment 117 is closed and end segment 118is open to allow for introduction of gas during blow molding.

Stock tube 116 is in a substantially non-molten state when it is ejectedfrom injection mold 220. In some embodiments, stock tube 116 is at atemperature between Tg and Tm when ejected from injection mold 220. Inalternative embodiments, stock tube 116 is at a temperature below Tgwhen ejected from injection mold 220.

The injection molded item, namely stock tube 216, has no pattern ofstent struts and no radial perforations distributed across thelongitudinal length of the stent.

Next, as shown in FIG. 3C, stock tube 116 is place within blow mold 220.The step of transferring stock tube 116 from injection mold 200 to blowmold 220 can be done before stock tube 116 is able to cool to atemperature that is either: (a) below a desired process temperature (Tp)predetermined to produce optimal results in the finished stent, whereTg<Tp<Tm; or (b) below Tg of the polymer resin. For example, stock tube116 can be actively cooled or quenched within injection mold 200 or uponremoval from injection mold 200.

Blow mold 220 has an interior diameter 226 which is greater than themaximum outer diameter 209 of the circumferential wall of stock tube 116to allow for radial expansion of the circumferential wall. Interiorsurface 224 of blow mold 220 limits radial expansion of thecircumferential wall. Optionally, blow molding including the applicationof heat is performed as described in U.S. Pub. Nos. 2009/0001633 and/or2011/0066222.

FIG. 3D shows the result after gas is pumped into the interior of stocktube 216. At this stage, the expanded stock tube is referred to asprecursor tube 234.

FIG. 3E shows precursor tube 234 after having been removed from blowmold 220.

As shown in FIG. 3F, precursor tube 234 can be carried on cylindricalmandrel 236 and placed adjacent cutter 238 for removing portions ofprecursor tube 234 to form a network of stent struts. Perforation 239has been made by cutter 238 through precursor tube 234. With removal ofmaterial, precursor tube 234 is transformed to a stent having a networkof stent struts. Mandrel 236 is inserted within precursor tube 234 andcan be connected to rotation motor and gear assembly 240 a and slidemotor and gear assembly 240 b under computer numerical control (CNC).Relative movement between mandrel 236 and cutter 238 can be programmedinto a CNC software application operating within electronic controller242 to provide the desired pattern of stent struts.

In the above-described system and method, the polymer material or resincan be any synthetic or naturally occurring polymer suitable forimplantation. Without limitation, the material can be selected from thegroup consisting of poly(L-lactide) (“PLLA”),poly(L-lactide-co-glycolide) (“PLGA”), poly(L-lactide-co-D-lactide)(“PLLA-co-PDLA”) with less than 10% D-lactide, and PLLD/PDLAstereocomplex, and PLLA-based polyester block copolymer containing arigid segment and a soft segment, the rigid segment being PLLA or PLGA,the soft segment being PCL or PTMC.

In the above-described system and method, material is removed from theprecursor tube to transform the precursor tube to a stent having stentstruts arranged in any pattern. The stent struts can have the patternsdescribed in U.S. Pub. No. 2008/0275537 of application Ser. No.12/114,608 filed May 2, 2008 and U.S. Pat. No. 7,476,245 issued Jan. 13,2009. For example, the pattern can include stent struts arranged in arepeating pattern of W-shaped cells as described in Pub. No.2008/0275537 or in a repeating pattern of hour-glass shaped cells asdescribed in U.S. Pat. No. 7,476,245. The shape of the cells cancorrespond to perforations 139 and 239 in FIGS. 2F and 3F. The patterncan include a series of longitudinally arranged rings, each ring havingan undulating series of stent struts oriented at oblique angles to eachother, and each one of the rings is connected to an adjacent ring byother stent struts oriented substantially parallel to the longitudinalaxis of the stent. The present invention is not limited to anyparticular pattern.

In the above-described system and method, the first mold or theinjection mold can have an annular mold cavity having inner diameter IDand outer diameter OD and the second mold or the blow mold can have acylindrical mold cavity having a diameter D. The amount of radialexpansion which the stock tube undergoes depends upon the dimensionalrelationship between the two mold cavities. Without limitation, thefollowing approximate dimensions for ID, OD, and D can be used.

EXAMPLE 1

-   -   ID=about 0.17 mm; OD=about 0.41 mm; D=about 3.5 mm

EXAMPLE 2

-   -   ID=about 0.13 mm; OD=about 0.40 mm; D=about 3 mm

EXAMPLE 3

-   -   ID=about 0.11 mm; OD=about 0.34 mm; D=about 2.5 mm

The dimensions of the two mold cavities can be such that thecircumferential wall of the substrate undergoes a radial expansion (RE)ratio in the range of about 300% to about 400%. RE ratio is defined as(Inside Diameter of Precursor Tube)/(Inside Diameter of Stock Tube). REratio as a percentage is defined as (RE ratio−1)×100%.

While several particular forms of the invention have been illustratedand described, it will also be apparent that various modifications canbe made without departing from the scope of the invention. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the invention. Accordingly, it is not intended that theinvention be limited, except as by the appended claims.

What is claimed is:
 1. A system for forming a polymer endoprosthesis,the system comprising: an injection mold having an injection moldcavity; a blow mold having a blow mold cavity; and a door movable froman first position to a second position, the injection mold cavity andthe blow mold cavity being separated from each other by the door when atthe first position, the injection mold cavity and the blow mold cavitybeing exposed to each other with when the door is at the secondposition.
 2. The system of claim 1, further comprising a cutterconfigured to make perforations through the precursor tube.
 3. Thesystem of claim 1, wherein the injection mold cavity is annular in shapeand is configured to form a cylindrical tube when polymer material isinjected into the injection mold.
 4. The system of claim 1, wherein theblow mold cavity has a diameter greater than that of the injection moldcavity.
 5. The system of claim 1, wherein the injection mold includes anejector configured to push contents of the injection mold cavity intothe blow mold cavity.